Kornimate/medical-research-clean huggingface dataset:
role of goal directed fluid therapy in enhanced recovery after surgery in gastro-intestinal oncosurgeries

Conditions: Fluid Loss; Enhanced Recovery

Summary: enhanced recovery after surgery (eras) protocols are multimodal perioperative care pathways designed to achieve early recovery and reducing postoperative morbidity after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery .the key elements of eras protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens , goal directed fluid therapy early mobilization.

for the proposed study investigators plan to include total 60 patients with 30 each allotted to gdft(svv) and cvp group ,belonging to asa ( american society of anesthesiology)grade i/ii/iii, study will be conducted after obtaining written informed consent from all patients and approval from the scientific committee and institutional review board (irb). all patients will receive one-third starvation fluid as crystalloid during first hour of surgery . night prior to and on the day of surgery carbo load will be given to all patients according to the protocol.monitoring included 5 lead ecg spo2,etco2, invasive blood pressure (ibp - radial),cvp(site ijv),core temperature . standard general anaesthesia with oral endotracheal tube and intermittent positive pressure ventilation will be given to all patients.patients will be allotted randomly to either goal directed fluid therapy (gdft) /svv - stroke volume variation or conventional central venous pressure - cvp guided fluid therapy group. during the surgery - heart rate , mean arterial blood pressure , urine output , blood loss , seum lactate levels will be noted. for svv group - svv , stroke volume index (svi) , systemic vascular resistance index (svri) ,cardiac index (ci) values will be noted every 30 minutes- the goal is to maintain svv value \>11 and to give colloid bolus 200ml whenever svv values rise above11.pre and post bolus svv, sv, svi and svri shall be recorded. for cvp group - goal is to maintain cvp values between 8-12 cmsh20 and for decrease in value \< 8 colloid bolus of 200ml will be given and change in cvp value will be noted. patients in both the groups will receive noradrenaline infusion if map \<70 mmhg with optimal fluid transfusion .target for transfusing packed red blood cells will be value of haematocrit \< 24 postoperative hr, map, i/o-charting, serum creatinine, serum lactate, bowel sounds, inotrope requirement, visual analogue score, ryles tube feeds, epidural analgesia ,length of stay (hours in sicu) and any postoperative complications shall be noted.

Eligibility criteria:
inclusion criteria: * elective major open gastrointestinal oncosurgeries . exclusion criteria: * patient refusal. * robotic surgery. * laparoscopic surgery. * arrythmias.

Keywords: goal directed fluid therapy stroke volume variation enhanced recovery after surgery
effects of l-arginine on myocardial energetic efficiency and global longitudinal strain

Conditions: Myocardial Dysfunction

Summary: the study is designed to evaluate the effects of l-arginine on myocardial structure and function and circulating micrornas in patients with arterial hypertension. the study will analyze the impact of 4 weeks treatment randomized to l-arginine or placebo, on mechanical-energy efficiency (mee) and longitudinal strain in patients with arterial hypertension. the investigators will also assess whether the changes in mee and strain induced by l-arginine treatment is associated with changes in circulating micro rnas.

the patients and controls will be recruited at the hypertension research center of federico ii university hospital. the overall duration of the study will be 4 weeks for each participant. blood pressure, heart rate, echocardiogram and blood sample will be collected for each patients at randomization and after 4 weeks of treatment. patients or controls will be randomized to receive bioarginine (up to 2 vials per os of 1.66 g every 12 hours) or placebo (up to 2 vials per os without active substance every 12 hours). before the start of treatment, patients will receive a peripheral venous blood sample (10-12 ml), which will be identified through the use of an alphanumeric code (pre-xxxyyy). in addition, patients will undergo full echocardiographic examination (the parameters will be reported in a password-protected database, using the same identification codes used for blood sampling). the duration of the treatment will be 4 weeks. at the end of the treatment, the patients will receive a peripheral venous blood sample (10-12 ml) which will be identified through the use of an alphanumeric code (post-xxxyyy) and full echocardiographic examination. in some controls, we will run an explorative study to verify the eventual impact of bioarginine on standardized physical exercise. healthy controls will undergo a physical exercise according to their preference, at baseline and after 4 weeks of treatment or placebo. ear lobe blood samples are taken before and after the effort and analyzed for serum lactate content using the reflectance photometric enzymatic reaction method. all l-arginine and placebo, made up of the l-arginine vehicle without the active substance, will be offered free of charge by the farmaceutici damor company.

Eligibility criteria:
inclusion criteria: * low values of mechanical-energy efficiency * sinus rhytm exclusion criteria: * atrial fibrillation * taking beta blockers * pregnancy * cancer

Keywords: hypertension echocardiography global longitudinal strain
assessment of walking-related fatigability in patients with multiple sclerosis.

Conditions: Multiple Sclerosis

Summary: the primary goal of this interventional study is to objectively examine the prevalence of walking-related performance fatigability, together with the psychometric properties of its measuring parameters. the secondary aim is to investigate the relation of other clinical symptoms to walking-related performance fatigability. the following three research questions will be addressed: 1. how prevalent is walking-related performance fatigability and what are the psychometric properties of fatigability formulas in preparation of use as experimental outcome measure? 2. what are associated symptoms of walking-related motor fatigability and how long does this manifest? 3. what is the relationship between cognitive fatigability and walking-related performance fatigability? participants perform two six-minute walking test (6mwt), with 3-5 days in between. before and after the 6mwt, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, si) on a vas scale. these screening tests and si are continued every 10 minutes for half an hour. during a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6mwt to investigate the relationship between cognitive and motor fatigability.


Eligibility criteria:
inclusion criteria: * age between 18 - 70 years * confirmed diagnosis according to the mcdonald criteria * performed a 6mwt before, to ensure familiarization * able to walk independently or with unilateral support for 6 minutes without rest * signed the informed consent exclusion criteria: * exacerbation or relapse within last 3 months before study * other neurological diagnosis, such as stroke and parkinson * ms-like syndromes, such as neuromyelitis optica * other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia)
double-blind placebo-controlled cin trial

Conditions: Acute Kidney Injury

Summary: this double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following iv iodine-based contrast material administration in subjects with stage iiib or stage iv chronic kidney disease. subjects will be scheduled for clinically indicated ct of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. the primary outcome measure will be the incidence of stage ii aki by akin (acute kidney injury network) criteria.

this double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodine-based contrast material administration in subjects with stage iiib or stage iv chronic kidney disease. subjects will be scheduled for clinically indicated ct of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. the primary outcome measure will be the incidence of stage ii aki by akin criteria. secondary outcome measures will include aki by other definitions (stage i aki, traditional ci-aki definition), hospital length of stay, 30-day readmission rate, number of additional percutaneous interventions within 30 days, number of additional ct examinations within 30 days, and 30-day mortality rate. all subjects will receive a minimum of 1 ml/kg/hr (max: 125 ml/hr) of volume expansion for at least three hours before and after the ct..

Eligibility criteria:
inclusion criteria: * inpatients scheduled for ct scan of abdomen and/or pelvis * had surgery in the last 4 weeks * stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each other, with most recent within 5 days of ct) * suspected infection or fluid collection in abdomen and/or pelvis exclusion criteria: * pregnant * severe allergy (anaphylaxis) to contrast * dialysis in last 7 days * received intravascular iodinated contrast in last 48 hours * ct of abdomen and pelvis in last 7 days shows no fluid collection * prisoners * ct ordered for an indication that requires (eg, ct angiogram) or contraindicates (eg, renal stone ct) the administration of intravascular contrast

Keywords: ct, iodinated contrast, contrast-induced aki, kidney injury
efficacy of dead sea peloid gel in chronic endometritis

Conditions: Chronic Endometritis

Summary: this study evaluates the effect of dead sea peloid gel in the treatment of chronic endometritis in women with reproductive disorders. half of participants will receive dead sea peloid gel and antibiotics, while the other half will receive placebo gel and antibiotics. patients with reproductive disorders who visited research medical center of family health problems and human reproduction were recruited.

dead sea peloid gel achieves improvement of blood circulation and receptor sensitivity of endometrium.

Eligibility criteria:
inclusion criteria: * women with miscarriage associated with chronic endometritis * women without mental disorders able to swallow tablets exclusion criteria: clinical diagnosis of: * sexually transmitted diseases * endometrium hyperplasia and/or polyps * uterina fibroids * endocrine disorders * trombophilia

Keywords: chronic endometritis miscarriage infertility
a clinical trial of mirror treatment for phantom pain

Conditions: Phantom Limb Pain; Complex Regional Pain Syndromes

Summary: a randomized controlled clinical to examine the effect of mirror therapy on phantom pain and residual limb pain in patients with traumatic transtibial amputations in cambodia. the study will be conducted with a semi-crossover design using self-rated pain and function as the main result variables.

the study will be conducted in two phases: firstly, the effects of mirror treatment (m) versus tactile treatment (t) will be compared in an open, randomized, semi-cross-over case-control design study. the second phase includes the responders from the initial treatment (m or t), the duration of the initial treatment effect will be observed, and the effect of a second round of similar treatment will be registered. phase one: the study patients will be randomized for m or t treatment. the main outcome variables will be gathered before the initial randomization and after an initial treatment period of three weeks. non-responders (nr) will be allocated for an immediate second three-weeks treatment period of combined treatment (m+t); the responders (r) of the m, t and m+t enter the second phase of the study. the m+t non-responders discontinue the study. phase two: the responders will be observed for a period of maximum three months. when symptoms of phantom limb pain and/or crps resume, the patients will undergo a second treatment period with the same treatment as during phase one. the duration of the second treatment period will be maximum three weeks, but each patient may decide to interrupt the treatment at an earlier stage if he finds the effect satisfactory. the main outcome indicators will be gathered at the start and the end of the second treatment period. the study closes at the end of the second treatment period. for both study phases the treatment effects will be compared between the strata and also inside each stratum, using each patient as his own control.

Eligibility criteria:
inclusion criteria: * present age \>16 years. * unilateral trans-tibial land mine amputation more than 12 months before entering the study. * suffering from phantom limb pain and/or crps-2. exclusion criteria: * amputation stump anomalies that require surgical reconstructions such as chronic infections, neuroma or major soft tissue deformities. * chronic alcoholism or drug abuse. * loss or deformities of limbs other than the actual amputation. * mental and/or cognitive disorders making self-reporting unreliable.
intra-operative assessment of the intellirod loadpro spinal rod strain sensor for use during kyphotic corrective surgery

Conditions: Kyphosis; Spinal Fractures

Summary: the loadpro study is an intra-operative, non-significant risk (nsr) case series feasibility assessment of the intellirod loadpro™ system measuring spinal rod strain in long spinal kyphotic corrective constructs.

the intellirod loadpro™ sensor is an intra-operative titanium and ceramic, single use, disposable, strain sensing device, which includes hermetically sealed, micro electromechanical systems (mems) and radio-frequency identification (rfid) technology to enable measurement of intra-operative rod strain values. the transponder attaches to any commercially available 5.5mm diameter cocr or ti alloy rod commonly used for posterior pedicle fixation systems. the transponder is used only to acquire rod strain values and a unique device identification code, which is obtained by a hand-held reader, providing real-time, objective measurement of the mechanical rod strain. this non-significant risk case series is intended to assess the effectiveness of the intellirod loadpro™ sensor methodology and the intra-operative measurement of spinal rod strain. the loadpro™ sensors will be removed from the spinal rods after obtaining load measurements.

Eligibility criteria:
inclusion criteria: * between 18 and 65 years of age * presenting with a confirmed diagnosis of kyphosis with deformity greater than 70 degrees requiring large segmental correction involving a minimum of six (6) levels * failure of conservative therapy requiring surgical correction of sagittal imbalance * sagittal imbalance due to loss of lumbar lordosis, and/or segmental kyphosis * participated in the informed consent process and has signed an institutional review board approved informed consent exclusion criteria: * women who are pregnant * evidence of active (systemic or local) infection at time of surgery * prisoner or transient * history of known narcotic abuse * psychological disturbance past or present that could impair the consent process or ability to complete subject self-report questionnaires * asa \> 3 * osteoporosis diagnosed on dexa defined as a t-score ≥ -2.0 * unable or unwilling to provide a full informed consent

Keywords: kyphotic corrective surgery spinal fractures
effects of upper extremity low volume hiit in heart failure

Conditions: High Intensity Interval Training; Heart Failure; Exercises

Summary: this study was planned to investigate the effects of upper extremity low-volume high-intensity interval training (lv-hiit) on physical and cognitive function in patients with heart failure with preserved ejection fraction(hfpef).the research was planned as a randomized controlled trial. patients with clinically stable hfpef at cardiology clinic will be included in the study. these cases will be randomly divided into two groups: intervention group and control grup. after 8 weeks intervention physical functions before and after treatment; functional exercise capacity, arm exercise capacities , peripheral muscle strength , fatigue cognitive functions; anxiety and depression and fear of movement will be evaluated.

patients in the dv-hiit group will receive training consisting of 4 minutes of warm-up and cool-down at 50% wmax on an arm ergometer, 1 minute of training at 85-95% wmax work intensity, followed by 6 interval training periods including 1 minute of active recovery periods at 50-70% wmax, 2 days/week, totaling 8 weeks of training. the control group will be followed with standard medical treatment.

Eligibility criteria:
inclusion criteria: * clinical condition stable for ≥4 weeks. * new york heart association functional classification i-ii to iii * over 18 years old exclusion criteria: history of cabg surgery * unstable angina pectoris * severe arrhythmia * acute pericarditis, endocarditis, myocarditis * severe left ventricular failure (ef \<40%) * acute pulmonary embolism * history of syncope * dissecting aneurysm * thrombophlebitis * orthopedic disorders that may interfere with exercise * uncontrolled hypertension, severe pulmonary arterial hypertension * moderate-severe valve disease * decompensated congestive heart failure * electrolyte abnormalities * hypertrophic cardiomyopathy

Keywords: high intensity interval training upper extremity exercises capacity
effect of repeated botulinum toxin injection on gait pattern in stroke patients

Conditions: Botulinum Toxins Injection in Stroke Patients

Summary: chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(bti). several studies demonstrated that single bti-session in a single muscle of paretic lower limb(ll) improved kinematic gait parameters(gp) but surprisingly none of them assessed the effects of repetitive multifocal bti on patient's gait pattern and their duration. the aim was to evaluate the impact of repetitive multifocal bti-sessions on gp of chronic stroke patients. to that end, gait of patients will be compared using 3d-gait analysis after 3 consecutives bti sessions.

all the patients will be treated with bti . these injections will be performed under electrical stimulation control (\~5ma). the dose, the number of site of injection per muscle is at the discretion of the physician according to patients' needs and physicians' routine clinical practice. the dilution the most commonly used will be 100 u for 2.5ml (xeomin®)

Eligibility criteria:
inclusion criteria: * \>18 years * a single hemispheric cerebral vascular lesion more than 6 months previously * able to walk 10 meters without any assistance * having benefited of at least 2 consecutive bti sessions, second 3d gait analysis performed at least 3 months after the last bti. exclusion criteria: * patient's refusal to participate to the study * inability to read the selected text * inability to cooperate * no affiliation to social security

Keywords: botulinum toxin injections stroke 3d motion analysis gait pattern
safety and preliminary efficacy of the treatment of kidney allografts with curcumin-containing preservation solution

Conditions: End Stage Renal Failure With Renal Transplant

Summary: the safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin complex (cdc) solution to graft perfusion solution is studied. cdc has proved safe and highly effective in preventing primary graft non-function, delayed graft function and chronic dysfunction in pre-clinical kidney transplantation animal models. the hypothesis is that addition of cdc to the graft perfusion solution will decrease the incidence of delayed graft function in human kidney transplantation subjects.


Eligibility criteria:
inclusion criteria: * patients with esrd assigned for kidney transplantation, written informed consent exclusion criteria: * none
a study of ab801 monotherapy and combination therapy in participants with advanced malignancies

Conditions: Advanced Cancer

Summary: the primary purpose of this study is to assess the safety and tolerability of ab801 in participants with advanced malignancies, and to determine a recommended ab801 dose for expansion.


Eligibility criteria:
key inclusion criteria: * monotherapy-specific criteria for dose escalation cohorts: * participants may have cytologically or pathologically confirmed non-small cell lung carcinoma (nsclc), colorectal carcinoma (crc), breast, ovarian, renal cell carcinoma (rcc), head and neck squamous cell carcinoma (hnscc), or bladder (including urothelial malignancies of the renal pelvis and ureter) carcinoma that has progressed or was non-responsive to available therapies with no standard of care (soc) options, or for whom standard therapy has proven ineffective, intolerable, or considered inappropriate; or for whom a clinical study of an investigational agent is a recognized soc. * disease-specific criteria for dose-expansion (nsclc): * cytologically or pathologically confirmed locally advanced unresectable or metastatic (stage iiib-iv per american joint committee on cancer version 8) non-squamous nsclc negative for actionable mutations in egfr, alk, ros1, ntrk, c-met, or ret. mixed sclc and squamous nsclc histology is not permitted. * previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and pd-(l)-1inhibitor. * must have at least 1 measurable lesion per response evaluation criteria in solid tumors (recist) guidance (version 1.1) (section 1.1). the measurable lesion must be outside of a radiation field if the participant received prior radiation unless discussed and approved by the study physician. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. key exclusion criteria: * use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product. * underlying medical conditions or adverse events that, in the physician or sponsor's opinion, will make the administration of investigational products hazardous. * prolonged qt interval defined as mean corrected qt interval (qtc) ≥ 450 milliseconds (ms). * any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, wegner syndrome, hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment. * treatment with systemic immunosuppressive medication (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: ab801 non-small cell lung cancer (nsclc)